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Not yet recruitingNCT06063811CHANNELEDUpdated Oct 3, 2023

Ventricular Tachycardia Ablation in LVAD Patients

An observational study in Ventricular Tachycardia, End-stage Heart Failure and Ventricular Arrythmia, sponsored by Universitätsklinikum Köln. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-03.

Sponsored by Universitätsklinikum Köln · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study summary

The CHANNELED-Registry is a multicenter retrospective study to (1) systematically assess the mechanism and origin of ventricular tachycardia in patients with end-stage heart failure carrying an left ventricular assist device (LVAD) and (2) to evaluate procedural parameters and outcome of ventricular tachycardia ablation in this special subset of patients.

02

Conditions studied

  • Ventricular Tachycardia
  • End-stage Heart Failure
  • Ventricular Arrythmia
  • LVAD (Left Ventricular Assist Device)

Keywords

  • Catheter Ablation
  • VT Ablation in LVAD patients
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All patients with end-stage heart failure and an implanted LVAD which underwent ablation of ventricular tachycardia will be included in this retrospective observational study.

Inclusion criteria

  • All patients with end-stage heart failure with an LVAD implanted undergoing VT ablation

Exclusion criteria

Exclusion Criteria:

  • Patients \<18 years, pregnant women, patients undergoing VT ablation without an LVAD
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • LVAD patients

    Patients with end-stage heart failure with an LVAD implanted undergoing VT ablation.

    Other: Ablation

Interventions

  • OtherAblation

    VT ablation

05

What researchers measure

Primary outcomes

  1. Mechanism of ventricular tachycardia in LVAD patients (descriptive name of scale)

    Assessment of the mechanism of VT in LVAD patients (e.g LVAD cannula related vs. related to substrate of underlying heart disease)

    Time frame: 12 month

  2. Number of patients with ventricular tachycardia recurrence in device interrogation (physiological parameter)

    Assessment of VT recurrence after ablation: Device interrogation and readout of ICD Holter

    Time frame: 12 month

  3. Mortality (physiological parameter)

    Assessment of mortality after VT ablation.

    Time frame: 12 month

  4. Heart failure Hospitalization (physiological parameter)

    Assessment of Hospitalization for worsening of Heart Failure after VT ablation.

    Time frame: 12 month

Secondary outcomes

  1. Procedure duration (From groin puncture to sheath removal in minutes)

    Evaluation of the duration of VT ablation procedures in LVAD patients

    Time frame: 12 month

  2. Fluoroscopy time (minutes)

    Evaluation of the fluroscopy use (in minutes)

    Time frame: 12 month

  3. Radiofrequency energy used for ablation (in watts; e.g. 40 Watts)

    Evaluation of the maximum RF-energy used for ablation

    Time frame: 12 month

  4. Number of patients suffering from intraprocedural complication (physiological parameter, e.g. hematoma)

    Evaluation of intraprocedural complications of VT ablation

    Time frame: 12 month

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06063811
Lead sponsor
Universitätsklinikum Köln
Responsible party
Sponsor
First posted
Oct 3, 2023
Start date
Sep 25, 2023 (estimated)
Primary completion
Jan 15, 2024 (estimated)
Completion
May 15, 2024 (estimated)
Last update
Oct 3, 2023

Study contacts

Jakob Lüker, MD
Contact
jakob.lueker@uk-koeln.de
+49 221 478 82851
Jan-Hendrik van den Bruck, MD
Contact
jan-hendrik.van-den-bruck@uk-koeln.de
+49 221 478 84895
Jakob Lüker, MD
principal investigator · Heart Center University of Cologne

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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